Exploration of effects of galvanic vestibular stimulation on circadian rhythms and its associations with sleep and spatial memory in patients with breast cancer: The ICANSLEEP-2 protocol.

<h4>Background</h4>Patients with breast cancer (BC) exhibit circadian rhythm disruptions, mainly of rest-activity rhythm (RAR), of which sleep is an essential component, and cortisol rhythm. Sleep complaints such as insomnia and cognitive impairments are prevalent in BC. In general popul...

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Main Authors: Melvin Galin, Laura de Girolamo, Bénédicte Clarisse, Carine Segura-Djezzar, Franka Glöckner, Clara Elia, Stéphane Réhel, Patrice Clochon, Franck Doidy, Julien Chavant, Olivier Etard, Fausto Viader, Jean-Michel Grellard, Justine Lequesne, Florence Joly, Francis Eustache, Tristan Martin, Bénédicte Giffard, Gaëlle Quarck, Joy Perrier
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2024-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0306462
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author Melvin Galin
Laura de Girolamo
Bénédicte Clarisse
Carine Segura-Djezzar
Franka Glöckner
Clara Elia
Stéphane Réhel
Patrice Clochon
Franck Doidy
Julien Chavant
Olivier Etard
Fausto Viader
Jean-Michel Grellard
Justine Lequesne
Florence Joly
Francis Eustache
Tristan Martin
Bénédicte Giffard
Gaëlle Quarck
Joy Perrier
author_facet Melvin Galin
Laura de Girolamo
Bénédicte Clarisse
Carine Segura-Djezzar
Franka Glöckner
Clara Elia
Stéphane Réhel
Patrice Clochon
Franck Doidy
Julien Chavant
Olivier Etard
Fausto Viader
Jean-Michel Grellard
Justine Lequesne
Florence Joly
Francis Eustache
Tristan Martin
Bénédicte Giffard
Gaëlle Quarck
Joy Perrier
author_sort Melvin Galin
collection DOAJ
description <h4>Background</h4>Patients with breast cancer (BC) exhibit circadian rhythm disruptions, mainly of rest-activity rhythm (RAR), of which sleep is an essential component, and cortisol rhythm. Sleep complaints such as insomnia and cognitive impairments are prevalent in BC. In general population, sleep is known to contribute greatly to cognition. Thus, improving RAR (and particularly sleep) could help limiting cognitive impairments in BC patients. It has recently been suggested that, in addition to its essential role in spatial memory, the vestibular system contributes to RAR synchronization. Its stimulation could therefore limit both sleep disturbances and spatial memory deficits in BC.<h4>Objectives</h4>The main aim of the ICANSLEEP-2 study is to assess the effects of galvanic vestibular stimulation (GVS) on circadian rhythms. The secondary aim is to assess whether GVS improves sleep and spatial memory in BC patients.<h4>Methods</h4>Two groups with insomnia complaints (Insomnia Severity Index > 7) will be included: a patients' group with BC (n = 50) and a healthy control group without history of cancer (n = 25). There will be two assessment sessions, before and after 2 weeks of GVS. Patients will be randomly assigned to either a GVS group or a sham group (noneffective stimulation). Controls will receive GVS. GVS effects will be quantified and compared between groups. Assessments will include actigraphy, salivary cortisol, polysomnography, a cognitive test battery (including a computer-based task for spatial memory) and validated questionnaires (for psychological functioning and sleep complaints).<h4>Discussion</h4>Current methods for improving sleep in BC have had controversial outcomes regarding sleep structure. We expect GVS to offer a new mean of directly targeting RAR disruptions in BC patients, with beneficial effects on sleep structure. Given the crucial impact of sleep on cognitive functioning, notably spatial memory, improving sleep of BC patients should enhance their cognitive functioning.<h4>Ethics and dissemination</h4>This study received ethical approval from the Ile de France IV institutional review board on 19 April 2022 (no. ID-RCB: 2022-A00437-36). The findings yielded by this protocol will be presented at various conferences and in peer-reviewed journals.<h4>Clinicaltrials.gov registration number</h4>NCT05414357.
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institution Kabale University
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language English
publishDate 2024-01-01
publisher Public Library of Science (PLoS)
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spelling doaj-art-aef2e2ac27c7405eb4fd6f83f889ca7f2025-01-04T05:30:46ZengPublic Library of Science (PLoS)PLoS ONE1932-62032024-01-01197e030646210.1371/journal.pone.0306462Exploration of effects of galvanic vestibular stimulation on circadian rhythms and its associations with sleep and spatial memory in patients with breast cancer: The ICANSLEEP-2 protocol.Melvin GalinLaura de GirolamoBénédicte ClarisseCarine Segura-DjezzarFranka GlöcknerClara EliaStéphane RéhelPatrice ClochonFranck DoidyJulien ChavantOlivier EtardFausto ViaderJean-Michel GrellardJustine LequesneFlorence JolyFrancis EustacheTristan MartinBénédicte GiffardGaëlle QuarckJoy Perrier<h4>Background</h4>Patients with breast cancer (BC) exhibit circadian rhythm disruptions, mainly of rest-activity rhythm (RAR), of which sleep is an essential component, and cortisol rhythm. Sleep complaints such as insomnia and cognitive impairments are prevalent in BC. In general population, sleep is known to contribute greatly to cognition. Thus, improving RAR (and particularly sleep) could help limiting cognitive impairments in BC patients. It has recently been suggested that, in addition to its essential role in spatial memory, the vestibular system contributes to RAR synchronization. Its stimulation could therefore limit both sleep disturbances and spatial memory deficits in BC.<h4>Objectives</h4>The main aim of the ICANSLEEP-2 study is to assess the effects of galvanic vestibular stimulation (GVS) on circadian rhythms. The secondary aim is to assess whether GVS improves sleep and spatial memory in BC patients.<h4>Methods</h4>Two groups with insomnia complaints (Insomnia Severity Index > 7) will be included: a patients' group with BC (n = 50) and a healthy control group without history of cancer (n = 25). There will be two assessment sessions, before and after 2 weeks of GVS. Patients will be randomly assigned to either a GVS group or a sham group (noneffective stimulation). Controls will receive GVS. GVS effects will be quantified and compared between groups. Assessments will include actigraphy, salivary cortisol, polysomnography, a cognitive test battery (including a computer-based task for spatial memory) and validated questionnaires (for psychological functioning and sleep complaints).<h4>Discussion</h4>Current methods for improving sleep in BC have had controversial outcomes regarding sleep structure. We expect GVS to offer a new mean of directly targeting RAR disruptions in BC patients, with beneficial effects on sleep structure. Given the crucial impact of sleep on cognitive functioning, notably spatial memory, improving sleep of BC patients should enhance their cognitive functioning.<h4>Ethics and dissemination</h4>This study received ethical approval from the Ile de France IV institutional review board on 19 April 2022 (no. ID-RCB: 2022-A00437-36). The findings yielded by this protocol will be presented at various conferences and in peer-reviewed journals.<h4>Clinicaltrials.gov registration number</h4>NCT05414357.https://doi.org/10.1371/journal.pone.0306462
spellingShingle Melvin Galin
Laura de Girolamo
Bénédicte Clarisse
Carine Segura-Djezzar
Franka Glöckner
Clara Elia
Stéphane Réhel
Patrice Clochon
Franck Doidy
Julien Chavant
Olivier Etard
Fausto Viader
Jean-Michel Grellard
Justine Lequesne
Florence Joly
Francis Eustache
Tristan Martin
Bénédicte Giffard
Gaëlle Quarck
Joy Perrier
Exploration of effects of galvanic vestibular stimulation on circadian rhythms and its associations with sleep and spatial memory in patients with breast cancer: The ICANSLEEP-2 protocol.
PLoS ONE
title Exploration of effects of galvanic vestibular stimulation on circadian rhythms and its associations with sleep and spatial memory in patients with breast cancer: The ICANSLEEP-2 protocol.
title_full Exploration of effects of galvanic vestibular stimulation on circadian rhythms and its associations with sleep and spatial memory in patients with breast cancer: The ICANSLEEP-2 protocol.
title_fullStr Exploration of effects of galvanic vestibular stimulation on circadian rhythms and its associations with sleep and spatial memory in patients with breast cancer: The ICANSLEEP-2 protocol.
title_full_unstemmed Exploration of effects of galvanic vestibular stimulation on circadian rhythms and its associations with sleep and spatial memory in patients with breast cancer: The ICANSLEEP-2 protocol.
title_short Exploration of effects of galvanic vestibular stimulation on circadian rhythms and its associations with sleep and spatial memory in patients with breast cancer: The ICANSLEEP-2 protocol.
title_sort exploration of effects of galvanic vestibular stimulation on circadian rhythms and its associations with sleep and spatial memory in patients with breast cancer the icansleep 2 protocol
url https://doi.org/10.1371/journal.pone.0306462
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